Color indicating formulations

ABSTRACT

Color indicating chewing gum compositions comprising one or more color compounds are provided. The compositions demonstrate a visual color or shade change from start of chewing to the end of chewing and provide oral health benefits. Methods of producing a color changing chewing gum are also provided.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.62/266,503, filed on Dec. 11, 2015, which is incorporated by referenceherein in its entirety.

FIELD

The presently disclosed subject matter relates to color indicatingformulations, particularly for use in oral products. Specifically, thepresent disclosure is directed to color indicating formulations for usein chewing gum and methods of producing color changing chewing gum.

BACKGROUND

Various chewing gums that change color during mastication have beenproposed in the art. However, these chewing gums tend to depend oningredients that are pH-sensitive, e.g., colorants that change colorwith a change in pH. Such chewing gums depend on the pH of saliva toinitialize the change in color. Color changing chewing gums were alsolimited in color possibilities for both pre-chew and post-chew colors.Further, such chewing gums often changed color over very shorttime-spans, for example, five minutes or less.

The physical act of chewing increases the flow of saliva in the mouth.Chewing after eating increases salivary flow, which can increase oralhygiene. Benefits of increased salivary flow include, but are notlimited to 1) removing food debris, 2) neutralizing and washing away theacids that are produced when food is broken down by the bacteria withindental plaque, 3) carrying more calcium and phosphate to help strengthenand remineralize tooth enamel, and 4) reducing oral dryness. Clinicalstudies have shown that chewing sugarless gum for 20 minutes followingmeals can help prevent tooth decay. When brushing teeth is not asuitable option, chewing sugarless gum is a great way to help keep teethclean and healthy after eating or drinking.

Chewing gum is also an effective booster of cognitive performance,including but not limited to mood enhancement, concentration, memory,and alertness—and without side effects.

Chewing gum that delivers a variety of therapeutic agents could provideadditional benefits to those gums currently being offered by the abilityto mechanically stimulate saliva flow. For instance, some gum mightcontain active agents that could enhance the gum's ability toremineralize teeth and reduce decay, or enable gum to help reduce plaqueand gingivitis. Chewing gum is often also used as a delivery system foractive ingredients, such a teeth whiteners and pharmaceuticals. Uponchewing, such active ingredients are solubilized by saliva and deliveredto the subject. However, different active ingredients require differentchewing times to deliver the necessary amount of active ingredient.Additionally, to achieve the benefits of increased salivary flow andboost cognitive performance, the gum must be chewed for a specificamount of time. Therefore, there remains a need for chewing gums thatindicate to a consumer when a chewing gum has been sufficientlymasticated to provide benefits to the consumer.

The presently disclosed subject matter addresses this need as discussedin detail below.

SUMMARY OF THE INVENTION

The presently disclosed subject matter is directed to chewing gumcompositions comprising at least one water soluble color compound andoptionally at least one water insoluble color compound, where the atleast one water soluble compound leaches out of the chewing gum afterfrom about 5 minutes to about 20 minutes of chewing.

In certain embodiments, the at least one water soluble color compound isselected from the group consisting of any water soluble dye, FD&C Blue 1dye, FD&C Blue 2 dye, liquid caramel (regular or low 4 MEI), FD&C Red40, FD&C Red 3, FD&C Yellow 5, FD&C Yellow 6, FD&C Green 3, fruit andvegetable based colorants (anthocyanins, betanin), spirulina, gardenia,and combinations thereof.

In certain embodiments, the at least one water insoluble color compoundis selected from the group consisting of any pigment, lake pigment,titanium dioxide, curcumin, iron oxides, FD&C Blue 1 lake, any FD&C foodgrade lake or oil soluble dye, beta carotene, other carotenoids, BetaApo 8′ Carotenal, canthaxanthin, chlorophylls, and combinations thereof.

In certain embodiments, the chewing gum further comprises an activeingredient. In certain embodiments, the active ingredient is a dentalactive agent.

In certain embodiments, the dental active agent is selected from thegroup consisting of sodium tripolyphosphate, sodium pyrophosphate (SPP),sodium hexametaphosphate, sodium bicarbonate, urea, lauroyl arginineethyl ether (LAE), allyl isothiocyanate, zinc lactate, zinc gluconate,tea polyphenols, pigallocatechin gallate (EGCG), cranberry extract,cocoa flavanoids, magnolia bark extract, and combinations thereof.

In certain embodiments, the active ingredient leaches out of the chewinggum in equal or fewer minutes as the at least one water soluble compoundleaches out of the chewing gum.

In certain embodiments, the chewing gum composition has at least about1% color change that occurs after about 5 minutes of chewing. In otherembodiments, the chewing gum composition has at least about 5% colorchange that occurs after about 10 minutes of chewing.

Another aspect of the presently disclosed subject matter provides amethod of producing a color changing chewing gum comprising the steps ofadmixing a gum base portion, a bulk portion, and a flavor, where atleast one color compound is admixed directly with the gum base portion,the bulk portion, or with both the gum base portion and the bulkportion.

In certain aspects, the presently disclosed subject matter provides amethod of producing a color changing chewing gum where at least onecolor compound is a water soluble color compound that is admixeddirectly with both the bulk portion and the gum base portion. Inalternative aspects, the presently disclosed subject matter provides amethod of producing a color changing chewing gum where at least onecolor compound is a water insoluble color compound that is admixeddirectly with both the bulk portion and the gum base portion. In otherembodiments, the presently disclosed subject matter provides a method ofproducing a color changing chewing gum where at least one color compoundis an oil soluble color compound that is admixed directly with both thebulk portion and the gum base portion.

In certain aspects, the method of producing a color changing chewing gumproduces a gum containing from about 0.05% to about 5.0% by weight of awater soluble color compound. In other aspects, the method produces acolor changing chewing gum containing from about 0.004% to about 5.0% byweight of a water insoluble color compound. In alternative aspects, themethod of producing a color changing chewing gum produces a gumcontaining from about 0.05% to about 5.0% by weight of a water solublecolor compound, and from about 0.004% to about 5.0% by weight of a waterinsoluble color compound. In another aspect, the method of producing acolor changing chewing gum produces a gum containing from 0.004% toabout 0.01% by weight of an oil soluble color compound. In certainaspects, the method of producing a color changing chewing gum produces agum containing from about 0.001% to about 5.0% by weight of a colorcompound selected from lakes, pigments, and combinations thereof.

The foregoing has outlined broadly the features and technical advantagesof the present disclosure in order that the detailed description thatfollows can be better understood. Additional features and advantages ofthe disclosure will be described hereinafter which form the subject ofthe claims of the disclosure. It should be appreciated by those skilledin the art that the conception and specific embodiment disclosed can bereadily utilized as a basis for modifying or designing other structuresfor carrying out the same purposes of the present disclosure. It shouldalso be realized by those skilled in the art that such equivalentconstructions do not depart from the spirit and scope of the applicationas set forth in the appended claims. The novel features which arebelieved to be characteristic of the application, both as to itsorganization and method of operation, together with further objects andadvantages will be better understood from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a-1 c display the change in lightness (y-axis) of a chewing gumover time (x-axis). Each chewing gum contained a different water solublecolor compound and was evaluated at T=0 minutes, 1 minute, 5 minutes, 10minutes, and 20 minutes of chewing.

FIGS. 2 a-2 b display the change in lightness (y-axis) of a chewing gumover time (x-axis). Each chewing gum contained a different waterinsoluble or oil soluble color compound and was evaluated at T=0minutes, 1 minute, 5 minutes, 10 minutes, and 20 minutes of chewing.

FIG. 3 illustrates the change of color in chewing gum from green toyellow and blue to white after 20 minutes of chewing.

DETAILED DESCRIPTION

As noted above, there remains a need in the art for color changingchewing gum formulations and methods for improving oral health ordelivering an active ingredient via chewing gum. The presently disclosedsubject matter addresses this need through the use of one or more colorcompounds that provide color-indicating features to indicate that thechewing gum has been masticated for a length of time sufficient toincrease oral health, deliver an active ingredient, or provide otherbenefits to the consumer.

1. Definitions

The terms used in this specification generally have their ordinarymeanings in the art, within the context of this disclosed subject matterand in the specific context where each term is used. Certain terms arediscussed below, or elsewhere in the specification, to provideadditional guidance to the practitioner in describing the compositionsand methods of the disclosed subject matter and how to make and usethem.

As used herein, the use of the word “a” or “an” when used in conjunctionwith the term “comprising” in the claims and/or the specification canmean “one,” but it is also consistent with the meaning of “one or more,”“at least one,” and “one or more than one.” Still further, the terms“having,” “including,” “containing” and “comprising” are interchangeableand one of skill in the art is cognizant that these terms are open endedterms.

The term “about” or “approximately” means within an acceptable errorrange for the particular value as determined by one of ordinary skill inthe art, which will depend in part on how the value is measured ordetermined, i.e., the limitations of the measurement system. Forexample, “about” can mean within 3 or more than 3 standard deviations,per the practice in the art. Alternatively, “about” can mean a range ofup to 20%, preferably up to 10%, more preferably up to 5%, and morepreferably still up to 1% of a given value.

As used herein, “admixing” refers to the process where the coloringformulation is mixed with or added to the completed product, or mixedwith some or all of the components of the product during productformation, or some combination of these steps. When used in the contextof admixing, the term “product” refers to the product or any of itscomponents. This admixing step can include a process selected from thestep of adding the coloring formulation to the product, spraying thecoloring formulation on the product, coating the coloring formulation onthe product, suspending the coloring formulation in the product,painting the coloring formulation on the product, pasting the coloringformulation on the product, encapsulating the product with the coloringformulation, mixing the coloring formulation with the product, and anycombination thereof. The coloring formulation can be a liquid, drypowder, spray, paste, suspension, and any combination thereof.

As used herein, the term “chewing gum” or “gum” refers to a flavoredsubstance intended for chewing. The term as used herein also includesbubble gum and confectionery products containing chewing gum. In certainembodiments, chewing gum forms include, but are not limited to, tablets,sticks, solid balls, hollow balls, cut and wrap, and pellets or pillows.Unless otherwise specified, all percentages used herein are weightpercents. As used herein, chewing gum contains a water insoluble gumbase portion and a water soluble bulk portion.

As used herein, the term “breath freshening agent” means compounds orcompositions that counteract malodor. Breath freshening agents include,but are not limited to, salts of zinc, salts of copper, polyphenols,mushroom extracts, and mixtures thereof.

As used herein, the term “mouth odor masking flavor” means compounds orcompositions that cover, mask, or overpower malodor. Mouth odor maskingflavors include, but are not limited to, cinnamon, mint, wintergreen,fruit flavors, and mixtures thereof.

As used herein, the term “dental active agent” means compounds orcompositions which promote oral health or deliver active ingredients tothe teeth. Dental active agents include, but are not limited to, toothwhiteners, fluoride, stain removers, calcium salts, phosphate salts, andmixtures thereof.

As used herein, the term “shade,” as in a color compounds which changes“shade,” visually means that the color becomes lighter or changes color(for example, green to yellow or blue to light blue) in appearance overa period of time.

2. Color Compounds

The present application relates to color indicating formulations thatinclude at least one, two, three, or more color compounds. In certainembodiments, the color compounds are water soluble. In certainembodiments, the color compounds are water insoluble. In certainembodiments, the color compounds are dyes. In further embodiments, thedyes are water soluble or oil soluble. In certain embodiments, the dyescan be incorporated into an oral care product which visibly changescolor or shade during chewing. In certain embodiments, the colorcompounds are a mixture of one or more water soluble colorants and/orone or more water insoluble colorants.

Color compounds can include, but are not limited to, food grade dyes andlakes (such as FD&C dyes and FD&C lake colorants), fruit and vegetablejuices/extracts (such as anthocyanins or betalains and other watersoluble dyes derived from natural or non-natural sources), titaniumdioxide, beta carotene, and other carotenoids, Beta Apo 8′ Carotenal,curcumin, iron oxides, carmine, carminic acid, chlorophylls, andcombinations thereof.

In certain embodiments, the color compounds are water soluble dyes.Water soluble dyes include, but are not limited to, FD&C Blue 1, FD&CBlue 2, FD&C Yellow 5, FD&C Yellow 6, FD&C Red 40, FD&C Red 3, liquidcaramel (regular or low 4 MEI), FD&C Green 3, fruit and vegetable andplant based colorants (anthocyanins, betanin), spirulina, gardenia,carthamus and combinations thereof.

In certain embodiments, the color compounds are water insoluble. Waterinsoluble color compounds include, but are not limited to, beta caroteneand other carotenoids, paprika oleoresin and extract, FD&C Blue 1 lake(brilliant blue lake), and all FD&C or synthetic food grade lakes or oilsoluble dyes, additional lake pigments, Beta Apo 8′ Carotenal, titaniumdioxide, curcumin, iron oxides, and combinations thereof.

In certain embodiments, the color compounds are oil soluble. Oil solubledyes include, but are not limited to, beta carotene, Beta Apo 8′Carotenal, paprika oleoresin, canthaxanthin, and combinations thereof.

In other embodiments, the color compounds are FD&C or non-FD&C colors.In further embodiments, the color compounds can be in liquid or powderform.

In certain embodiments, the color compounds can be incorporated intochewing gum formulations.

3. Chewing Gum Formulations

The presently disclosed subject matter can be incorporated into chewinggum using conventional procedures and equipment and suitable additionalcomponents known in the art, for example, as described by U.S.Publication Nos. 2013/0156885 and U.S. 2005/0202118, each of which isincorporated by reference in its entirety herein. A chewing gumcomposition can contain a chewable gum base portion, which isessentially free of water and is water insoluble; a water soluble bulkportion; and flavors, which can be water insoluble. The water solublebulk portion can dissipate with a portion of the flavor over a period oftime during chewing. The water insoluble gum base portion is retained inthe mouth throughout the chew.

In certain embodiments, color compounds can be admixed and added to thewater soluble bulk portion. In other embodiments, color compounds can beadmixed and added to the water insoluble gum base portion. In anotherembodiment, the color compounds can be admixed with both the watersoluble bulk portion and water insoluble gum base portion. Without beingbound to any particular theory, Applicant believes that oil solublecolor compounds and pigments have an affinity for the water insolublegum base portion, and the water soluble color compounds in the watersoluble bulk portion, or dispersed throughout the whole formulation,have an affinity for saliva upon chewing, which enables the chewing gumto change colors.

In certain embodiments, the insoluble gum base comprises elastomers,elastomer solvents, plasticizers, waxes, emulsifiers, and/or inorganicfillers. In certain embodiments, the insoluble gum base can compriseelastomers, elastomer solvents, plasticizers, waxes, emulsifiers and/orinorganic fillers. Plastic polymers, such as polyvinyl acetate, whichcan behave as plasticizers, can also be included. In certainembodiments, plastic polymers can include, but are not limited to,polyvinyl laureate, polyvinyl alcohol, and polyvinyl pyrrolidone.Non-limiting examples of elastomers can include polyisobutylene, butylrubber, (isobutylene-isoprene copolymer), and styrene butadiene rubber,as well as natural masticating substances such as chicle, etc. Incertain embodiments, elastomer solvents can include resins such asterpene resins. In certain embodiments, the plasticizers are fats andoils, including, but not limited to, tallow, hydrogenated and partiallyhydrogenated vegetable oils, and cocoa butter. In certain embodiments,the waxes include, but are not limited to, paraffin, microcrystalline,and natural waxes, such as beeswax and carnauba.

In certain embodiments, the chewing gum further contains one or moreflavor components that are derived from artificial, or natural sources,or combinations thereof. In certain embodiments, the chewing gum cancontain sugar or can be sugar-free. In certain embodiments, the chewinggum can comprise high potency sweeteners including, but not limited to,synthetic substances, saccharin, thaumatin, alitame, saccharin salts,aspartame, sucralose, stevia, and acesulfame.

In certain embodiments, the water insoluble gum base constitutes fromabout 5% to about 95% by weight of the chewing gum. In certainembodiments, the water insoluble gum base comprises from about 10% toabout 50% by weight of the chewing gum, or from about 20% to about 35%by weight of the chewing gum.

In certain embodiments, the high potency sweetener can comprise fromabout 0.02% to about 1.0% by weight of the chewing gum, or from about0.05% to about 0.5% by weight of the chewing gum.

In certain embodiments, the chewing gum has a neutral pH, e.g., fromabout 5.9 to about 8.0.

In certain embodiments, the chewing gum formation process can includemodification of one or more ingredients by encapsulation. In certainembodiments, encapsulation modifies the release of, for example, coolingcompounds, from the chewing gum by modifying the solubility ordissolution rate. Any standard technique which gives partial or fullencapsulation of the combination of natural cooling agents can be used.In certain embodiments of the presently disclosed subject matter,encapsulation techniques include, but are not limited to, spray drying,spray chilling, fluid-bed coating, and coacervation. In certainembodiments, encapsulation techniques that give partial encapsulation orfull encapsulation can be used.

In certain embodiments, suitable encapsulating materials can include,but are not limited to, water soluble sugar or sugar alcohol such assorbitol, isomalt, dextrose, erythritol, lactitol, maltitol, mannitol,xylitol, hydrogenated corn syrup, and mixtures thereof. In certainembodiments, encapsulating materials can also include water solublestarch, modified starch, hydroxyl methyl cellulose, hydroxypropylmethylcellulose (HPMC), sodium alginate, alpha, beta and gammacyclodextrin, polymers, and combinations thereof. In certainembodiments, the coating compositions can be susceptible to waterpermeation to various degrees. In certain embodiments, the coatingcomposition is a food grade material.

The chewing gum can include one or more of the following: anti-microbialagents; anti-plaque agents; physiological cooling agents; breathfreshening agents; breath freshening and mouth odor masking flavors;dental active agents; and combinations thereof.

Dental active agents include, but are not limited to, tooth whiteners,fluoride, stain removers, stain preventing actives, anti-inflammationcompounds, anti-cavity compounds, calcium salts, phosphate salts, andmixtures thereof.

In certain embodiments, tooth whiteners include, but are not limited to,sodium tripolyphosphate (STPP or STP), sodium pyrophosphate (SPP),sodium hexametaphosphate, sodium bicarbonate, urea, lauroyl arginineethyl ether (LAE), and combinations thereof. In certain embodiments,STPP, STP, sodium hexametaphosphate, sodium bicarbonate, or urea ispresent in the gum composition in an amount of about 0.01% to about 10%by weight. In certain embodiments, LAE is present in the gum compositionin an amount of about 0.01% to about 5% by weight.

Anti-microbial and anti-plaque agents include, but are not limited to,cardamom oil, magnolia bark extract (MBE), cranberry, geraniol,cinnamaldehyde, peppermint, triclosan, chlorhexidine, cetyl pyridiniumchloride (CPC), LAE, and mixtures thereof. In certain embodiments,magnolia bark extract is present in the gum composition in an amount offrom about 0.01% to about 5% by weight. In certain embodiments, LAE ispresent in the gum composition in an amount of from about 0.01% to about5% by weight.

Physiological cooling agents include menthol N-2,3-trimethyl-2-isopropylbutanamide, 3-1-menthoxypropane-1,2-diol,N-ethyl-p-menthane-3-carboxamide, menthane ketals, menthyl succinate,isopulegol, menthyl glutarate, and mixtures thereof.

Breath freshening agents include, but are not limited to, salts of zinc,salts of copper, polyphenols, mushroom extracts, allyl isothiocyanate(AITC), zinc lactate, zinc gluconate, magnolia bark extract, otherantibacterial agents that kill germ causing bad breath, or mixturesthereof. In certain embodiments, AITC is present in the gum compositionin an amount of from about 0.01% to about 1% by weight. In certainembodiments, zinc lactate is present in the gum composition in an amountof from about 0.01% to about 5% by weight. In certain embodiments, zincgluconate is present in the gum composition in an amount of from about0.01% to about 5% by weight.

Breath freshening and mouth odor masking flavors include, but are notlimited to, cinnamon, mint, wintergreen, fruit flavors, and mixturesthereof.

Anti-inflammation compounds include, but are not limited to, MBE, teapolyphenols, pigallocatechin gallate (EGCG), cranberry extract, cocoaflavanoids, and combinations thereof.

In certain embodiments, the chewing gum formulation can include one ormore color compounds.

4. Color Indicating Chewing Gum

The present application relates to color indicator formulations thatinclude at least one, two, three, or more color compounds. Theformulations can be incorporated into chewing gum formulations asdiscussed above.

In certain embodiments, water soluble color compounds can be admixeddirectly or added to the water soluble portion bulk portion. In otherembodiments, water insoluble or oil soluble color compounds can beadmixed directly or added to the water insoluble gum base portion. Inother embodiments, color compounds can be admixed directly, added,and/or incorporated into the water soluble bulk portion, the waterinsoluble gum base portion, or both the water soluble bulk portion andwater insoluble gum base portion.

In certain embodiments, mastication causes the one or more water solublecolor compounds to leach into the saliva, changing the visual color ofthe gum. This can occur after from about 5 minutes to about 20 minutesof chewing. In some embodiments, the gum becomes whiter in color aschewing proceeds. In other embodiments, oil soluble color isincorporated into the water insoluble base portion. Alternatively, theoil soluble compound, lake, or pigment is incorporated into both thewater insoluble gum base portion and the water soluble bulk portion ofthe chewing gum. The oil soluble compounds can stay within the chewinggum matrix during chewing. As the one or more water soluble colorcompounds leach into the saliva, the gum visually alters to appear asthe color of the oil soluble or water insoluble color compound, thusindicating to the consumer that the gum has been sufficiently masticatedto provide benefits. Alternatively, the gum visually alters to appear adifferent shade of the original color, e.g., lighter, or alters from onecolor to another, e.g., green to yellow.

In certain embodiments, the water soluble color compound admixed withthe water soluble bulk portion is blue in color, e.g., FD&C Blue 1, FD&CBlue 2, or combinations thereof. Upon chewing, as the water solublecolor compound leaches into the saliva, the gum can turn from colored(for example, blue) to uncolored or off-white/white. In otherembodiments, as the water soluble color compound leaches into thesaliva, the gum can turn from colored (for example, blue) to a differentshade of the color (for example, light blue).

In certain embodiments, the water soluble color compound admixed withthe water soluble bulk portion is blue in color, and the water insolubleor oil soluble color compound admixed with the water insoluble gum baseportion is yellow in color, e.g., beta carotene. The unchewed gumtherefore can appear green in color. Upon chewing, the gum can turn fromgreen to yellow as the water soluble color compound leaches into thesaliva.

In certain embodiments, the visual color change of the gum occursindependently of the pH of saliva.

In certain embodiments, the color compound levels present within the gumare set within a good manufacturing practice (“GMP”) standard, or withincolor regulation limits. In certain embodiments, the water soluble oroil soluble color compound can be present within the gum in an amount offrom about 0.0001% to about 6.0% by weight, or from about 0.05% to about5.0% by weight. In certain embodiments, the water soluble or oil solublecolor compound is a dye and can be present within the gum in an amountof from about 0.001% to about 0.2% by weight. In other embodiments, thecolor compound is a water insoluble pigment or lake, such as FD&C Blue 1lake, and can be present within the gum in an amount of from about0.001% to about 2.0% by weight, or from about 0.004% to about 0.3% byweight.

In other embodiments, the color changing chewing gum contains from about0.05% to about 5.0% by weight of a water soluble color compound, andfrom about 0.004% to about 5.0% by weight of a water insoluble colorcompound. In certain embodiments, the color changing chewing gumcontains from about 0.004% to about 5.0% by weight of an oil soluble, orfrom about 0.004% to about 0.01% by weight of an oil soluble colorcompound. In another embodiment, a lake, pigment, and/or combinationthereof is present within the gum from about 0.001% to about 5.0% byweight, or from about 0.05% to about 2.0% by weight.

In certain embodiments, FD&C Blue 1 dye can be present within the gum inan amount of from about 0.001% to about 0.5% by weight. In certainembodiments, FD&C Blue 1 dye can be present within the gum in an amountof about 0.014% or about 0.066% by weight.

In certain embodiments, FD&C Blue 2 dye can be present within the gum inan amount of from about 0.001% to about 5.0% by weight. In certainembodiments, FD&C Blue 2 dye can be present within the gum in an amountof about 0.024% or about 0.1% by weight.

In certain embodiments, beta carotene can be present within the gum inan amount of from about 0.0001% to about 5.0% by weight. In certainembodiments, beta carotene can be present within the gum in an amount ofabout 0.0012% by weight. In some embodiments, the beta carotene presentwithin the gum is from spirulina.

In certain embodiments, spirulina can be present within the gum in anamount of from about 0.0001% to about 5.0% by weight. In certainembodiments, spirulina can be present within the gum in an amount ofabout 1.0% by weight.

In certain non-limiting embodiments, the color changing chewing gum canhave a combination of several water soluble color compounds and/orseveral water insoluble or oil soluble color compounds. In someembodiments, a color changing chewing gum can comprise a yellow colorcompound (e.g., beta carotene) with FD&C Blue 1 dye and FD&C Blue 2 dye.In one embodiment, a gum can comprise about 0.004% by weight of a yellowcolor compound, about 0.014% by weight of FD&C Blue 1 dye, and about0.24% by weight of FD&C Blue 2 dye. In another embodiment, the colorchanging chewing gum can comprise a yellow color compound and spirulina.

In certain embodiments, the water soluble color compounds can beselected based on the length of time required for an active ingredientcompound to leach into the saliva, such as 1 minute, 5 minutes, 10minutes, or 20 minutes. In some embodiments, the active ingredientleaches out of the chewing gum in equal or fewer minutes as at least onewater soluble color compound leaches out of the chewing gum. In certainnon-limiting embodiments, the total time for a visual color or shadechange and active ingredient delivery is at least about 5 minutes, atleast about 10 minutes, at least about 15 minutes, or at least about 20minutes.

The total time for the color or shade change can be the same timerequired for a dental active, e.g., xylitol, to effectively be deliveredto the oral cavity.

In certain embodiments, the color compounds can be selected to changethe chewing gum color or shade based on the length of time required toincrease oral hygiene. An increase in oral hygiene can include, but isnot limited to, removing food debris, neutralizing and washing away theacids that are produced when food is broken down by the bacteria withindental plaque, strengthening and remineralizing tooth enamel, and/orreducing oral dryness. In certain embodiments, the color indicating chewgum changes color or shade over a length of time effective to increasesalivary flow. In certain embodiments, the color compounds can beselected to change color or shade over an amount of time effective todecrease tooth decay.

In certain embodiments, the color indicating chewing gum changes colorover about 20 minutes of chewing. In other embodiments, the colorindicating chewing gum can exhibit at least a 1% color change afterabout 5 minutes of chewing. In certain embodiments, the color indicatingchewing gum can exhibit at least a 5% color change after about 10minutes of chewing.

In certain embodiments, the color compounds can be selected to changethe chewing gum color or shade over an amount of time effective toincrease cognitive performance. In certain embodiments, an increase incognitive performance can include, but is not limited to, enhancingmood, concentration, memory, and/or alertness.

In certain embodiments, the presently disclosed subject matter can beadministered to a mammal in amounts effective to increase oral hygiene,increase salivary flow, deliver an active ingredient, and/or increasecognitive performance. In certain embodiments, the color indicatingchewing gum can be administered one, two, three, or more times per dayto achieve these benefits.

In certain embodiments, the presently disclosed subject matter canprovide for a kit comprising one or more pieces of color indicatingchewing gum. In certain embodiments, each chewing gum is provided forseparate administration over a specific course of time, for example, perday, per week, or per month, to effectively increase oral hygiene,increase salivary flow, deliver an active ingredient, and/or increasecognitive performance.

EXAMPLES

The presently disclosed subject matter will be better understood byreference to the following Examples, which are provided as exemplary ofthe disclosed subject matter, and not by way of limitation.

Example 1: Water Soluble Color Compounds

In this Example, the percent color change of an unchewed gum as comparedto a chewed gum was measured using various water soluble colorcompounds.

A. Methods

FD&C Blue 1 dye, FD&C Blue 2 dye, and caramel liquid color wereindividually incorporated into a chewing gum formulation. Three levelsof each dye were tested: low color level, medium color level, and highcolor level as summarized in Table 1.

TABLE 1 Levels of dyes tested Low Level (%) Medium Level (%) High Level(%) FD&C Blue 1 dye 0.0012 0.066 0.2 FD&C Blue 2 dye 0.003 0.05 0.1caramel liquid 0.3 1.0 5.0 color Chewing gum of each level was chewed by5 subjects. Each cud was measured for lightness (L*) using a MinoltaSpectrophotometer at T = 0 minutes, 1 minute, 5 minutes, 10 minutes, and20 minutes of chewing. L* was calculated using a L*a*b* color space, acolor-opponent space with dimension L for lightness. L* was evaluatedfrom 0-100 where 0 was the darkest black and 100 was the brightestwhite.

B. Results

The polyol present in the gum base provided opacity to unchewed gums,resulting in a higher L* value. Once the gum was chewed, the polyol wassolubilized, reducing opacity and therefore reducing the L* value. Thisis seen in FIG. 1 at 1 minute. Even though the chewing gum centersappeared not to have color, the gum center also changed color and becamewhiter over time. This was due to the inherent color provided by the gumbase and additional ingredients.

The results for each color compound are summarized in FIGS. 1 a-1 c .FD&C Blue 1 dye demonstrated a cyan blue shade in the gum matrix,unchewed, as it was added from a pre-solubilized solution. FD&C Blue 2dye demonstrated a flag blue/blue-red shade for the same reasons.

Example 2: Water Insoluble Color Compounds

In this Example, the percent color change of an unchewed gum as comparedto a chewed gum was measured using various water insoluble or oilsoluble color compounds.

A. Methods

FD&C Blue 1 lake and beta carotene were incorporated into a chewing gumformulation. The beta carotene was added at three different levels:0.0006% (“low color level”), 0.004% (“medium color level”), and 0.03%(“high color level”) by weight. FD&C Blue 1 lake was present at about0.02% by weight. The gums were tested using the same procedure asExample 1.

B. Results

The results for each color compound are summarized in FIGS. 2 a-2 b .Beta carotene had an affinity for the hydrophobic gum matrix and stayedwithin the gum cud during chewing.

Example 3: Green to Yellow Color Indicating Gum

In this Example, chewing gum was formulated and visually changed fromgreen to yellow in color upon chewing.

A. Methods

FD&C Blue 1 dye and beta carotene were jointly incorporated into onechewing gum formulation which appeared green in color. The gums weretested using the same procedure as Example 1

B. Results

The color change results are illustrated in FIG. 3 . Over the course of20 minutes of chewing, the FD&C Blue 1 dye leached into the saliva. Thischanged the color of the chewing gum from green to yellow over the 20minute period as the beta carotene remained in the gum or cud.

Although the presently disclosed subject matter and its advantages havebeen described in detail, it should be understood that various changes,substitutions and alterations can be made herein without departing fromthe spirit and scope of the disclosed subject matter as defined by theappended claims. Moreover, the scope of the present disclosure is notintended to be limited to the particular embodiments of the process,machine, manufacture, composition of matter, means, methods and stepsdescribed in the specification. As one of ordinary skill in the art willreadily appreciate from the disclosure of the presently disclosedsubject matter, processes, machines, manufacture, compositions ofmatter, means, methods, or steps, presently existing or later to bedeveloped that perform substantially the same function or achievesubstantially the same result as the corresponding embodiments describedherein can be utilized according to the presently disclosed subjectmatter. Accordingly, the appended claims are intended to include withintheir scope such processes, machines, manufacture, compositions ofmatter, means, methods, or steps.

Patents, patent applications publications product descriptions, andprotocols are cited throughout this application the disclosures of whichare incorporated herein by reference in their entireties for allpurposes.

What is claimed is:
 1. A chewing gum composition comprising: a waterinsoluble gum base; at least one water soluble color compound selectedfrom the group consisting of FD&C Blue 1 dye, FD&C Blue 2 dye, liquidcaramel, FD&C Red 40, FD&C Red 3, FD&C Yellow 5, FD&C Yellow 6, FD&CGreen 3, betanin, and combinations thereof; and at least one waterinsoluble color compound incorporated into the water insoluble gum base,wherein the at least one water insoluble color compound is selected fromthe group consisting of lake pigment, curcumin, iron oxides, FD&C Blue 1lake, beta carotene, Beta Apo 8′ Carotenal, canthaxanthin, andcombinations thereof; wherein the at least one water soluble colorcompound leaches out of the chewing gum into the saliva after from about5 minutes to about 20 minutes of chewing to change the visual color ofthe gum to a color of the at least one water insoluble color compound,and wherein the at least one water insoluble color compound stays withinthe chewing gum base during chewing.
 2. The chewing gum composition ofclaim 1, further comprising an active ingredient.
 3. The chewing gumcomposition of claim 2, wherein the active ingredient is a dental activeagent.
 4. The chewing gum composition of claim 3, wherein the dentalactive agent is selected from the group consisting of sodiumtripolyphosphate, sodium pyrophosphate (SPP), sodium hexametaphosphate,sodium bicarbonate, urea, lauroyl arginine ethyl ether (LAE), allylisothiocyanate, zinc lactate, zinc gluconate, tea polyphenols,pigallocatechin gallate (EGCG), cranberry extract, cocoa flavonoids,magnolia bark extract, and combinations thereof.
 5. The chewing gumcomposition of claim 2, wherein the active ingredient leaches out of thechewing gum in equal or fewer minutes as the at least one water solublecolor compound leaches out of the chewing gum.
 6. The chewing gumcomposition of claim 1, wherein at least about 1% color change occursafter about 5 minutes of chewing.
 7. The chewing gum composition ofclaim 1, wherein at least about 5% color change occurs after about 10minutes of chewing.
 8. A chewing gum composition comprising: a waterinsoluble gum base; at least one water soluble color compound selectedfrom the group consisting of FD&C Blue 1 dye, FD&C Blue 2 dye, liquidcaramel, FD&C Red 40, FD&C Red 3, FD&C Yellow 5, FD&C Yellow 6, FD&CGreen 3, betanin, and combinations thereof; and at least one waterinsoluble color compound incorporated into the water insoluble gum base,wherein the at least one water insoluble color compound is selected fromthe group consisting of lake pigment, curcumin, iron oxides, FD&C Blue 1lake, beta carotene, Beta Apo 8′ Carotenal, canthaxanthin, andcombinations thereof; wherein the at least one water soluble colorcompound leaches out of the chewing gum into the saliva after from about5 minutes to about 20 minutes of chewing to change the visual color ofthe gum from a combined visual color of the at least one water solublecolor compound and the at least one water insoluble color compound to avisual color of only the at least one water insoluble compound, andwherein the at least one water insoluble color compound stays within thechewing gum base during chewing.
 9. The chewing gum composition of claim8, further comprising an active ingredient.
 10. The chewing gumcomposition of claim 9, wherein the active ingredient is a dental activeagent.
 11. The chewing gum composition of claim 10, wherein the dentalactive agent is selected from the group consisting of sodiumtripolyphosphate, sodium pyrophosphate (SPP), sodium hexametaphosphate,sodium bicarbonate, urea, lauroyl arginine ethyl ether (LAE), allylisothiocyanate, zinc lactate, zinc gluconate, tea polyphenols,pigallocatechin gallate (EGCG), cranberry extract, cocoa flavonoids,magnolia bark extract, and combinations thereof.
 12. The chewing gumcomposition of claim 9, wherein the active ingredient leaches out of thechewing gum in equal or fewer minutes as the at least one water solublecolor compound leaches out of the chewing gum.
 13. The chewing gumcomposition of claim 8, wherein at least about 1% color change occursafter about 5 minutes of chewing.
 14. The chewing gum composition ofclaim 8, wherein at least about 5% color change occurs after about 10minutes of chewing.